Thioridazine Hydrochloride

ANDA 89602, held by Ani Pharms. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 89602 (Thioridazine Hydrochloride), held by Ani Pharms, was first approved by FDA on Nov 9, 1987, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1987
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 9, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride30MG/ML · concentrate;oral	Thioridazine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jun 17, 1999	Supplement 7Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 6Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 5Manufacturing	Approved	None posted
May 31, 1996	Supplement 4Manufacturing	Approved	None posted
Nov 17, 1992	Supplement 3Manufacturing	Approved	None posted
Jul 7, 1992	Supplement 2Manufacturing	Approved	None posted
Mar 26, 1991	Supplement 1Labeling	Approved	None posted
Nov 9, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89602
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters